MitraClip Russia Trial

NCT04350372 | Completed Results FDA Device

• 1 other identifier: ABT-CIP 10334
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for patients at high risk for open-heart surgery. Treatment with the MitraClip device allows patients to undergo a less invasive procedure that can mechanistically reduce MR and allow for improved quality of life. The MitraClip procedure is performed under general anesthesia without the use of a heart-lung machine, with recovery typically lasting two to three days. The objective of this study is to evaluate safety and effectiveness of the MitraClip NT procedure in the Russian population for treatment of Mitral Regurgitation.

Conditions

Functional Mitral Regurgitation; Degenerrative Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Successful Implantation of the MitraClip NT Device

  Successful implantation of the MitraClip NT device resulting in a decrease in the MR severity grade as assessed from the discharge echocardiogram (10-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge will be considered a failure for the procedure

  30-day

Study Arms (1)

MitraClip

EXPERIMENTAL

Subject will receive MitraClip procedure with MitraClip NT System

Device: MitraClip Procedure

Interventions

MitraClip Procedure DEVICE

MitraClip procedure with MitraClip NT System

MitraClip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic DMR or FMR determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days or transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration.
• LVEF ≥ 30%
• NYHA classification is class II, class III, or ambulatory class IV.
• Subject is deemed difficult for mitral valve surgery due to either STS surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors (Porcelain aorta or mobile ascending aortic atheroma, Post-radiation mediastinum, Previous mediastinitis, Functional MR with LVEF\<40%, Over 75 years old with LVEF\<40%, Re-operation with patent grafts, Two or more prior cardiothoracic surgeries, Hepatic cirrhosis, Other surgical risk factor(s))
• Mitral valve area ≥ 4.0 cm2.
• The primary regurgitant jet is non-commisural, and in the opinion of the implanting investigator can successfully be treated by the MitraClip NT System. If a secondary jet exists, it must be considered clinically insignificant

You may not qualify if:

• Subject is currently participating in another clinical investigation
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow up period
• Patients with the following conditions: Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.
• Contraindications for reusable accessories (stabilizer, lift, support plate)
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

FSBI "NICC of Cardiology" of the Ministry

Moscow, Russia

Location

Results Point of Contact

• Title: Karine Miquel
• Organization: Abbott Structural Heart

karine.miquel@abbott.com

+32 479 600 107

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 17, 2020
• Study Start: February 18, 2020
• Primary Completion: September 24, 2020
• Study Completion: October 2, 2020
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)